<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220912055952N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-24</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of adding sufentanil and  dexamethasone to ropivacaine 0.1% in  painless labor</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of adding sufentanil and  dexamethasone to ropivacaine 0.1% in  painless labor with epidural anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65901</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of the block randomization type.
The size of all the blocks is equal and due to having two groups, there should be an equal number of states A and B in each block, which due to the volume of four blocks, there were six different states for the blocks, which are: AABB, ABAB, ABBA BBAA, BABA, BAAB.
In order to conceal, we use allocation concealment, which refers to the method used to perform a random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual.
The cards randomly and by re-replacing the selection and order of the blocks determine the order of placing the patients in groups A and B. A person who has no knowledge about the research will be used to select the cards on which the six states of blocks of four were written, Blinding description: In this study, in order to observe the blinding of the patients, the anesthesiologist will completely randomly divide them into two groups receiving the mixture of ropivacaine and dexamethasone (group A) and the mixture of ropivacaine and fentanyl (group B).
In both groups, the drugs used for the intervention are the same in terms of transparency and color, and the anesthesiologist has labeled each of them A and B. The syringes used are also the same shape, the same color, and completely similar, and to comply with blinding, the volume is 10 cc. It is delivered by the anesthesiologist in such a way that the anesthesiologist and patients and the intern responsible for data recording will not be able to identify the content of the solution from their appearance. The intern responsible for the project did not know the type of study groups from the beginning and is only responsible for filling out the questionnaires of the project and therefore the project will be implemented in a double-blind manner. In other words, the patient and the anesthesiologist responsible for drug injection and the intern responsible for data recording will be blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Painless labor.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: in 52 patients, 8 mg of dexamethasone (Alborz Daru-Iran) which was increased to 10 cc with 0.1% ropivacaine (Darmanyab Daru-Iran) will be slowly injecting by an anesthesiologist in the epidural space. Intervention 2: The second intervention group: in 52 patients, the amount of 0.25 mg per cc of sufentanil drug (Daru pakhsh-Iran) mixed with 10 cc of ropivacaine 0.1% (Darmanyab Daru-Iran) will be slowly injecting by an anesthesiologist in the epidural space.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Setayesh Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar azam complex, Basij Sq., Sardasht Town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176341</zip>
        <telephone>+98 86 3417 3520</telephone>
        <email>Setaayesh.hashemi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Setayesh Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar azam complex, Basij Sq., Sardasht Town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176341</zip>
        <telephone>+98 86 3417 3520</telephone>
        <email>Setaayesh.hashemi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Term pregnancy
Singleton pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Allergy to any of the drugs used
The presence of spinal deformities
Presence of coagulopathy
History of heart/pulmonary/kidney/liver disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: in 52 patients, 8 mg of dexamethasone (Alborz Daru-Iran) which was increased to 10 cc with 0.1% ropivacaine (Darmanyab Daru-Iran) will be slowly injecting by an anesthesiologist in the epidural space.</i_keyword>
      <i_keyword>The second intervention group: in 52 patients, the amount of 0.25 mg per cc of sufentanil drug (Daru pakhsh-Iran) mixed with 10 cc of ropivacaine 0.1% (Darmanyab Daru-Iran) will be slowly injecting by an anesthesiologist in the epidural space.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of pain relief. Timepoint: At 15, 30 and 60 minutes after epidural injection. Method of measurement: Visual Analogue Scale of pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Headache. Timepoint: Up to 6 hours after delivery. Method of measurement: Clinical interview.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: Up to 6 hours after delivery. Method of measurement: Clinical interview.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-03</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Payambar azam complex, Basij Sq., Sardasht Town Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
